Brand Name | 2CM PERIPHERAL CUTTING BALLOON |
Type of Device | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
two scimed place |
maple grove MN 55311 |
|
MDR Report Key | 11066007 |
MDR Text Key | 223443241 |
Report Number | 2134265-2020-18400 |
Device Sequence Number | 1 |
Product Code |
LIT
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Type of Report
| Initial,Followup |
Report Date |
12/24/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/23/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/08/2022 |
Device Model Number | 24628 |
Device Catalogue Number | 24628 |
Device Lot Number | 0025685764 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 12/24/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|